Sr. Specialist, External Manufacturing Quality Assurance

Role Summary

The Senior Specialist, External Manufacturing Quality Assurance is responsible for quality oversight of the Contract Manufacturing Organization (CMO) operations for Radiopharmaceutical products in accordance with business agreements, regulatory standards, and RayzeBio procedures. The scope includes clinical and commercial products as well as Standard of Care products, in accordance with RayzeBio policies, standards, procedures and global current Good Manufacturing Practice (cGMP). The Senior Specialist provides Quality support and oversight for CMO operations and disposition activities including review and approval of Deviations, CAPAs, Change Controls, documents, Batch Records, and Lot Disposition. This person will also interact with the Qualified Person (QP) as needed to facilitate release of EU doses.

Responsibilities

• Support Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations.
• Develops and implements policies and procedures for CMO compliance, including development of applicable Quality Agreements, Quality Business Processes, Product Disposition, and Quality Event Resolution in accordance with organizational strategy and business realities.
• Ensures approved quality systems are established and maintained to RayzeBio's quality standards and regulatory requirements.
• Partner closely with CMOs and RayzeBio's leadership team to ensure consistent and collaborative messaging to external manufacturing partners.
• Work cross functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners. Provide communication, support, and guidance to manufacturing partners and within the QA team. Effectively communicate issues, risks and proposed solutions within the organization.
• Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation related to Externally Manufactured product.
• Identify and report discrepancies from required work practices or procedures to management.
• Make sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.
• Participate as requested in the response team for audits and inspections by health authorities.

Qualifications

• Required: Minimum of 5 years' experience in quality assurance and/or compliance roles in the pharmaceutical industry.
• Preferred: Hands-on experience with QA oversight of contract manufacturing organizations is highly desired, but applicable quality experience will be considered.

Education

• BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred

Skills

• Expertise in GMP, Quality, material and product disposition
• Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles
• Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from management
• Strong project management skills and organizational ability to follow projects through to completion
• Team player who can work independently to achieve objectives in a fast-paced environment
• Excellent verbal and written communication skills.
• Audit and inspection management experience.
• Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired.
• Knowledge of US, EU and rest-of-world cGMP regulations and guidance.
• Knowledge and proven experience in FDA, EMA, or other regulatory authority.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Previous work responsibility, which required a high degree of attention to detail.
• Well-practiced in exercising sound judgment in decision-making.
• Demonstrated prioritization and organization skills.

Additional Requirements

• Physical Demands: While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision.